Prevention and control of blood transfusion-related infectious diseases has become the focus of the whole society, the introduction of new technologies for further improving blood safety is an important part. In the field of blood transfusion, blood transfusions inevitably present a certain degree of risk as some pathogens may be present in donated blood and blood components that can cause serious clinical consequences for recipients through blood transfusion. And a wide range of related pathogens, including viruses, bacteria, parasites and a protein. The risk of transmission of bacteria through blood transfusion is still high, such as the risk of bacterial contamination is higher 250 times than virus contamination of platelet products. Some countries in Europe since 1990 started bacterial detection on all platelet products, in 2004, the United States listed bacterial detection of platelet products as a indispensable examination items.
Bacterial cultivation method is currently recognized as the most accurate method of blood bacterial detection, blood service agencies are widely used in Europe, the United States, Canada and other countries. Such as BACT/ALERT system determines the concentration of bacteria by continuing to detect the concentration of carbon dioxide in the flask, the product should be stored for 24 hours before detection, so that bacteria reaches a certain number, while cultivation also take some time to achieve positive results, usually more than 72 h. PALL EBDS detects bacterial contamination by continuously measuring oxygen consumption in the sample bag. Bacteria also need to be incubated for 24 hours. Therefore, the bacterial cultivation method is time-consuming, corresponding system configuration and maintenance costs are very high, meanwhile, because of bacterial growth with hysteresis, the bacterial cultivation method is prone to false negative results.
Rapid detection method avoids the long time-consuming defect of bacterial cultivation method, such as Scansystem, using monoclonal antibody platelet filtration, marking bacterial DNA left in the sample using a transparent agent and fluorescent, determining pollution situation through laser scanning, positive report detection time shortens to 90 minutes, But its sensitivity is only 103 CFU/mL. Meanwhile, the system needs to distinguish the fluorescence signal, so it has high demand for the operator, and is difficult to promote it. At present, it is necessary to develop platelet bacterial detection equipment with high sensitivity, low cost, high-throughput to meet the blood screening and clinical diagnosis for the need of blood transfusion safety, reduce blood bacterial contamination rate, and ensure blood transfusion safety.
In the nucleic acid amplification, traditional PCR method is mostly used at present, but shortcomings of this method are low specificity, low sensitivity, slow detection speed, complex technical operation, and high requirements of the equipment, and is difficult to meet rapid diagnosis demand for grass-roots unit.